Quality Control Inspector Supervisor

Position Title: Quality Control Inspector Supervisor Department: Quality Reports to: Quality Operations Manager FLSA Status: Non-Exempt

Job Summary and Objectives:

Provide quality assurance support to the assigned program and/or area to ensure that all materials and incoming products meet customer and division quality requirements while maintaining departmental production flow. Regularly interact with representatives from a variety of functional groups, including design engineering, purchasing, operations, and all production and inspection personnel in the assigned product or program area. Manage calibration and maintenance programs to ensure compliance with applicable due dates. Initiate NCMRs as applicable to address out of tolerance calibration results.

Essential Duties and Responsibilities:

• Supervise and coordinate activities related to quality control including staffing, scheduling, coordinating, and planning or administration of an organization’s total quality management (TQM) program.
• Supervise department personnel responsible for inspection and reports on material, processes, and incoming products to ensure compliance with the company’s quality standards. Plan and establish schedules and track performance against estimates.
• Communicate information on the latest standards and procedures. Ensure all personnel are properly trained to the company’s quality systems including organizing and coordinating programs and training related to product quality.
• Document discrepancies and perform follow-up inspection of corrective actions taken.
• Schedule calibration and preventive maintenance.
• Remove equipment from service when needed due to calibration and/or preventive maintenance due dates.

Quality Control Inspector Supervisor

Job Description

DPH-0000-10172 Revision: 02 Page 2 of 4 Confidential: This document contains information that is the confidential and proprietary property of NextPhase Medical Devices LLC. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of NextPhase Medical Devices LLC.

• Maintain equipment files.
• Recommend and/or implement appropriate corrective action to quality problems in the assigned area, in conjunction with manufacturing engineering, design engineering, purchasing, etc.
• Exhibit in depth knowledge of inspection, configuration, measurement methods and techniques.
• Possess initiative to recommend changes or improvements to documentation, inspection methods or related criteria.
• Performs such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhase Medical Devices LLC may from time-to-time assign to the employee.

Supervisory Responsibilities [if applicable]:

• Supervise a team of inspectors.
• Make recommendations on hiring, promoting, discipline, or firing employees.

Required Qualifications and Work Experience:

• Minimum Education and Experience:
• 5 – 8 years experience in Quality Control Inspection.
• A working knowledge of industry practices and current technology is required, as well as computer literacy and proficiency in utilizing appropriate software.
• Excellent documentation, writing and communication skills.
• A working knowledge of FDA Quality System regulations.
• Skills/Abilities:
• Ability to coach and lead the inspection team.
• Ability to triage issues and identify relevant solutions.
• Ability to read and interpret documents such as mechanical drawings, part drawings, schematic diagrams, work instructions, bill of materials and procedure manuals.
• Ability to communicate effectively through oral and written communications.
• Ability to work with others collaboratively.
• Attention to detail to understand and meet the requirements. Quality Control Inspector Supervisor

Job Description

DPH-0000-10172 Revision: 02 Page 3 of 4 Confidential: This document contains information that is the confidential and proprietary property of NextPhase Medical Devices LLC. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of NextPhase Medical Devices LLC.

• Strong organizational skills.
• Strong verbal communication skills.
• Demonstrated problem solving ability in a cross functional environment.
• Take responsibility for tasks and time management.
• Experience with working to time standards.

Preferred Qualifications and Work Experience:

• Education and Experience:
• 8 or more years experience in Quality Control Inspection.
• Prior experience as a Quality Control Inspector Supervisor.
• Additional Eligibility Qualifications:
• ASQ Certification is beneficial.

Physical Demands:

• Full range of motion for wrist, hand and finger dexterity.
• Ability to frequently sit, stand, walk, stoop, kneel, and crouch.
• Ability to regularly lift/push/carry on average 30 pounds and at times up to 45 pounds.
• Ability to use a microscope and/or magnifier lamp for visual inspection and evaluation.
• Ability to see up close and from a distance for visual inspection and evaluation.

Additional Information:

• This position requires 100% on-site attendance.
• Verifies work affecting quality independently and has the authority to perform these tasks as stated in the Essential Duties and Responsibilities section.

Job Description is a Guideline Only:

• This job description is a summary of the main functions and responsibilities of this position as it currently exists. It is not intended to be a complete and exhaustive list or description and may evolve and change over time in accordance with business and market demands.

Quality Control Inspector Supervisor

Job Description

DPH-0000-10172 Revision: 02 Page 4 of 4 Confidential: This document contains information that is the confidential and proprietary property of NextPhase Medical Devices LLC. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of NextPhase Medical Devices LLC.

• This job description is also not a contract, and NextPhase Medical Devices LLC may from time-to-time in its discretion revise, amend, and update this job description to better reflect the actual functions and responsibilities the employee performs.
• Duties, responsibilities, and activities may change at any time with or without notice.

Equal Employment Opportunity Statement:

• NextPhase Medical Devices LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.